Standardized Fecal Microbiota Transplantation for Ulcerative Colitis
Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis
The Second Hospital of Nanjing Medical University
500 participants
Feb 1, 2013
INTERVENTIONAL
Conditions
Summary
The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT for Ulcerative Colitis (UC), Crohn's diseases, irritable bowel syndrome (IBS) and constipation have also met with some success. This is an initial step into investigating the potential efficacy of standardized fecal bacteriotherapy through mid-gut (at least below duodenal papilla) for UC, the investigators propose to determine the efficiency and safety of FMT in a series of 500 patients with moderate to severe UC (Montreal classification).
Eligibility
Inclusion Criteria1
- Patients who had been diagnosed with UC through a combination of typical clinical symptoms, endoscopy, and histological criteria for at least 3 months, and patients who failed to achieve satisfactory efficacy for UC from the previous therapies.
Exclusion Criteria1
- Patients were excluded if accompanied by other severe diseases, including other intestinal diseases (e.g., Clostridioides difficile infection), malignant neoplasm, cardiopulmonary failure, and serious liver and kidney disease, refused to complete the follow-up, and underwent FMT or WMT before.
Interventions
Fecal microbiota transplantation by gastroscopy administration of fresh or frozen bacteria from healthy donor to the mid-gut or whole colon
Medications
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT01790061